Job Description: Education and Experience:
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• BS degree in Microbiology or a related scientific discipline with 1-2 years of experience.
Knowledge, Skills and Abilities:
• Knowledge of FDA's GLP or GMP (Good Manufacturing Practices) regulations are required
• Outstanding organizational skills
• Good verbal and written communication skills
• Keen attention to detail
• Flexible in order to meet deliverables in a fast paced environment
• Experience in a GMP Microbiology laboratory is desired
• Possess a strong understanding of basic Microsoft Office applications
• Experience with electronic notebooks
• Sustains up-to-date knowledge on applicable department and site standard practices related to GMP’s and safety
The candidate will be able to demonstrate excellent organizational and communication skills, adaptability to ever changing demands and will have the assurance to drive excellence in data generation. Ideally, the candidate will have experience in a GMP environment and operation of an environmental monitoring program including but not limited to the monitoring of cleanroom facilities and utilities. The candidate will complete a various level of complex tasks, as assigned, and interact successfully with a large, diverse group of people.
Key responsibilities include:
• Issuance of preliminary and final notifications of alert/action limit excursions and mold notifications
• Compile data necessary to assist with quality investigations in support of all EM programs supported
• Tracking and trending of microbial identifications
• Issuance of notification of the isolation of potential organisms of concern and reviewing previous data in order to determine the frequency and locations of other instances of the appearances of these organisms
• Issuance of final batch report memos
• Revise procedures as necessary
• Tracking of change controls related to EM Programs and Utility management.
• Generation of quarterly trend reports for all areas monitored
• Interact with management to suggest approaches to increase efficiency that will allow for better operations in the laboratory